Request for Nominations on the National Mammography Quality Assurance Advisory Committee, 6199-6200 [2018-02922]

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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product FARYDAK
(panobinostat). FARYDAK, in
combination with bortezomib and
dexamethasone, is indicated for the
treatment of patients with multiple
myeloma who have received at least 2
prior regimens, including bortezomib
and an immunomodulatory agent. This
indication is approved under
accelerated approval based on
progression free survival. Continued
approval for this indication may be
contingent upon verification and
description of clinical benefit in
confirmatory trials. Subsequent to this
approval, the USPTO received patent
term restoration applications for
FARYDAK (U.S. Patent Nos. 6,552,065;
6,833,384; and 7,067,551) from Novartis
AG, and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated October 15, 2015, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
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approval of FARYDAK represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
FARYDAK is 4,334 days. Of this time,
3,997 days occurred during the testing
phase of the regulatory review period,
while 337 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: April
15, 2003. The applicant claims April 15,
2002, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 15, 2003,
which was the first date after receipt of
the IND that the investigational studies
were allowed to proceed.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 24, 2014.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
FARYDAK (NDA 205353) was initially
submitted on March 24, 2014.
3. The date the application was
approved: February 23, 2015. FDA has
verified the applicant’s claim that NDA
205353 was approved on February 23,
2015.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,751 days or 5
years of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
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6199
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02868 Filed 2–12–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0417]
Request for Nominations on the
National Mammography Quality
Assurance Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on the National Mammography
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health notify FDA in
writing. FDA is also requesting
nominations for a nonvoting industry
representative to serve on the National
Mammography Quality Assurance
Advisory Committee. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for an
upcoming vacancy effective with this
notice.
SUMMARY:
Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by March 15, 2018 (see sections I
and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by March 15,
2018.
DATES:
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6200
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for a
nonvoting industry representative
should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Division of Workforce
Management, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5264, Silver Spring,
MD 20993, 301–796–5960, Fax: 301–
847–8505, email: margaret.ames@
fda.hhs.gov.
The
Agency is requesting nominations for a
nonvoting industry representative on
the National Mammography Quality
Assurance Advisory Committee:
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. General Description of the Committee
Duties
The Committee shall advise FDA on:
(1) Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging that should be
considered in the oversight of
mammography facilities; (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in these areas; (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and (9)
determining the costs and benefits of
compliance with these requirements.
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II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
´
´
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nominations
must include a current, complete
´
´
resume or curriculum vitae for each
nominee and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for a nonvoting
representative of industry interests are
encouraged from the mammography
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
PO 00000
Frm 00042
Fmt 4703
Sfmt 9990
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02922 Filed 2–12–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0002]
Hospira, Inc. et al.; Withdrawal of
Approval of 44 New Drug Applications
and 158 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 4, 2016 (81 FR
68427). The document announced the
withdrawal of approval of 44 new drug
applications and 158 abbreviated new
drug applications (ANDAs) from
multiple applicants, effective November
3, 2016. The document erroneously
included abbreviated new drug
application (ANDA) 075726 for
Pemoline Tablets, 18.75 milligrams
(mg), 37.5 mg, and 75 mg, held by
Mallinkrodt Pharmaceuticals, LLC. This
notice corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
In the
Federal Register of Tuesday, October 4,
2016, appearing on page 68427 in FR
Doc. 2016–23893, the following
correction is made:
1. On page 68430, in table 1, the entry
for ANDA 075726 is removed.
In a separate notice published in this
issue of the Federal Register, FDA is
withdrawing the approval of ANDA
075726 under 21 CFR 314.150(d).
SUPPLEMENTARY INFORMATION:
Dated: February 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02926 Filed 2–12–18; 8:45 am]
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Agencies

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6199-6200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0417]
Request for Nominations on the National Mammography Quality
Assurance Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on the National Mammography
Quality Assurance Advisory Committee in the Center for Devices and
Radiological Health notify FDA in writing. FDA is also requesting
nominations for a nonvoting industry representative to serve on the
National Mammography Quality Assurance Advisory Committee. A nominee
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative. Nominations will be accepted
for an upcoming vacancy effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by March 15,
2018 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by March 15, 2018.
[[Page 6200]]
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for a nonvoting
industry representative should be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail
to Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member of an FDA
advisory committee can also be obtained by visiting FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce
Management, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver
Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email:
[email protected].
SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for a
nonvoting industry representative on the National Mammography Quality
Assurance Advisory Committee:
I. General Description of the Committee Duties
The Committee shall advise FDA on: (1) Developing appropriate
quality standards and regulations for mammography facilities; (2)
developing appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging that should be considered in the oversight of mammography
facilities; (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in these areas; (8) determining whether there will
exist a sufficient number of medical physicists after October 1, 1999;
and (9) determining the costs and benefits of compliance with these
requirements.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
III. Nomination Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed
copy of the Acknowledgement and Consent form available at the FDA
Advisory Nomination Portal (see ADDRESSES). Nominations must also
specify the advisory committee for which the nominee is recommended.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will forward all nominations to
the organizations expressing interest in participating in the selection
process for the committee. (Persons who nominate themselves as
nonvoting industry representatives will not participate in the
selection process.)
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for a nonvoting representative of industry
interests are encouraged from the mammography manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02922 Filed 2-12-18; 8:45 am]
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